AAIPharma Expands Capacity of Parenteral Manufacturing Facility
News Dec 28, 2012
AAIPharma Services Corp. has announced that it is expanding the capacity and capabilities of its parenteral manufacturing facility in Charleston, S.C.
Facility expansions currently underway at AAIPharma’s Charleston location include the installation of compounding and aseptic processing suites to contain a newly acquired Monoblock vial filling machine, expansion of the microbiology laboratory and addition of on-site formulation development capabilities and enhanced analytical instrumentation.
“One of AAIPharma’s key offerings is the ability to provide our clients with low line loss techniques,” said Rob Goshert, vice president of sales and client services.
Goshert continued, “We are often challenged by our clients to minimize consumption of their expensive active ingredients, and one way AAIPharma has answered this challenge is through the use of specialized filling processes designed to minimize product loss.”
AAIPharma’s FDA- and EU-approved facility utilizes disposable product contact components and maintains redundant critical capabilities to minimize potential downtime.
The fill and finish capabilities support vial sizes from 2 mL to 50 mL and can include 100% weight check.
Manufactured products include solutions, lyophilized products, emulsions and suspensions with batch sizes ranging from a few hundred vials to twenty-thousand, or more.
“In addition to the new fill line, integration of our formulation development and technical services capabilities through the build-out of a new pilot suite allows us to seamlessly support the manufacturing process from development through scale-up, further enhancing our compound to clinic™ strategy” said Paul Maffuid, Ph.D., vice president of pharmaceutical operations.
Maffuid continued, “Expansion of the existing laboratories with a new clean room for on-site sterility testing using isolator technology continues our primary objective of providing a world-class parenteral manufacturing facility with all supporting infrastructure under one roof.”